FDA UDI
In Commercial Distribution
🇺🇸 United States
Unipack
DI: 10665973029389
·
Model: UBC-82200
·
UNIPACK MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Unipack
- Primary DI
- 10665973029389
- Version / Model
- UBC-82200
- Catalog Number
- UBC-82200
- Company Name
- UNIPACK MEDICAL CORPORATION
- Labeler DUNS
- 018319397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 2d6f5995-987c-498e-a068-26a8d20f7aa2
Device Description
Evac Canisters 82200 w/Mesh Screen 2-3/4" x 3-5/8
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHZ | Evacuator, oral cavity | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44943 | Surgical suction system collection container, reusable | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40665973029380 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 10665973029389 | GS1 | ||||
| Unit of Use | 00665973029382 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]